Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

NCT00818350 | Unknown Phase 1

• 1 other identifier: AGOC O1
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity. Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy. No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority. Several drugs have been used in second line for metastatic disease with poor results. The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine). No previous studies have been published with sunitinib in metastatic bladder cancer.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• To determine the antitumor efficacy ( response rate) of sunitinib

  12 weeks

Secondary Outcomes (2)

• QOL

  6 WEEKS

• TOXICITY ACCORDING NCI VERSION 3 CRITERIA

  EVERY WEEK

Study Arms (1)

SUNITINIB

EXPERIMENTAL

Drug: SUNITINIB

Interventions

SUNITINIB DRUG

50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING

Also known as: SUTENT

SUNITINIB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cytological confirmation of UROTHELIAL carcinoma
• Failure of Cisplatin-gemcitabine regimen as first-line
• Presence of measurable metastases
• Performance status 0-1 ECOG
• Age of 18 years or older
• Written informed consent
• Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).

You may not qualify if:

• administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)
• brain metastases
• significant cardiac events within the 6 months prior to study drug administration.

Sponsors & Collaborators

• Campania Younger Oncologists Association: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• DI LORENZO GIUSEPPE, PHD

  Campania Younger Oncologists Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 7, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2011
• Last Updated: January 7, 2009

Record last verified: 2009-01